Risk Based Monitoring of Study Conduct and Patient Data

By Marie Hanley / February 22, 2013

Given the complexity and uniqueness of clinical trials, no single risk based monitoring plan works for every study. Recently the Food and Drug Administration (FDA) has started encouraging sponsors to move from traditional, all on-site monitoring to using a risk-based approach.1

A risk-based approach combines on-site monitoring with remote monitoring facilitated by electronic capture and sharing of trial data. For remote monitoring to be effective, a risk assessment must be performed and included in the monitoring plan prior to the start of any clinical program.

The risk assessment should specify required levels of on-site and remote monitoring:

On-site monitoring should be used to evaluate aspects critical to the study integrity. Examples are informed consent, subjective endpoints, integrity of drug accountability and randomization, and source data verification.

Remote monitoring should concentrate on activities that can be thoroughly reviewed and monitored remotely. These would include verifying consistency and completeness of data or identifying sites with high error rates or protocol violations.

At the outset, tolerance levels for variability in functions such as data collection, protocol violations, and adverse event reporting must be set. In addition, the monitoring plan should be flexible enough that it can be adapted as the trial is underway. Sites with a high number of protocol violations or poor data quality may require additional on-site visits for specific instruction.

Remote, electronic monitoring is not only being used to reduce the number of site visits by study monitors. It is also being used as a means for reducing in-person patient visits. In January 2013, the FDA approved telemonitoring for collecting patient data in a phase II study of a hypertension drug to be used in patients with multiple sclerosis. In the study, use of telemonitoring will mean only two in-person visits by patients. And it will bring the cost of the clinical trial down to an estimated $1.5 million, in comparison with the $5 million to $10 million that a phase II study typically costs.2

For the 12-month study, data will be collected from wearable monitors of vital signs in 180 participants.3Investigators and participants will communicate through secure video interaction. Because data are collected frequently, it is hoped that patient safety will increase with faster recognition of adverse events.

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